Devices › Holder, ureteral catheter
Device brand name · Statlock device
Sl Foley Swivel Silicone Tricot 25bx: medical device reports filed with FDA
441 reports name it, 2017–2023. Manufacturer given most often on reports: C R Bard Covington -1018233. Product code EYJ.
- 441
- device reports naming the brand
- 0% of all MAUDE reports · about 48 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 97.7%
- classified as malfunction
- 94.6% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
441 medical device reports received by FDA name the brand "Sl Foley Swivel Silicone Tricot 25bx" (statlock device); the manufacturer given most often on reports is C R Bard Covington -1018233; received from April 2017 to December 2023. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
0 reports arrived in the 12 months to August 2026, and none in the 12 months before. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases. The event types recorded are malfunction (97.7%) and injury (2.3%); across all holder, ureteral catheter reports (product code EYJ) death is recorded in 0% and malfunction in 94.6%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are disconnection (47.8%), loss of or failure to bond (19.7%) and difficult to open or close (7.9%). The patient problems coded most often are no patient involvement, discomfort and appropriate clinical signs, symptoms and conditions term/code not available. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."
Reports by month, five years
Reports by the month FDA received them. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.
By year received
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 1,177 reports carrying product code EYJ. Event type is the filer's classification and is not verified by FDA.
Device problems coded
| Device problem (FDA code) | Reports | Share | Share across product code |
|---|---|---|---|
| Disconnection | 211 | 47.8% | 41.5% |
| Loss of or failure to bond | 87 | 19.7% | 15.7% |
| Difficult to open or close | 35 | 7.9% | 10.3% |
| Material fragmentation | 33 | 7.5% | 7.2% |
| Fitting problem | 29 | 6.6% | 8.8% |
| Breakthe device broke | 22 | 5% | 4.1% |
| Detachment of device or device componentpart of the device came off | 19 | 4.3% | 4.8% |
| Device slipped | 14 | 3.2% | 3.1% |
| Material separation | 13 | 2.9% | 2.1% |
| Failure to adhere or bond | 11 | 2.5% | 2.6% |
| Nonstandard device | 11 | 2.5% | 2.5% |
| Detachment of device component | 10 | 2.3% | 1.8% |
| Loose or intermittent connection | 10 | 2.3% | 2.2% |
| Device fell | 5 | 1.1% | 0.8% |
| Component falling | 4 | 0.9% | 1.2% |
| Failure to form staple | 4 | 0.9% | 0.4% |
| Patient-device incompatibilitythe device did not suit the patient | 4 | 0.9% | 1.3% |
| Biocompatibility | 3 | 0.7% | 0.4% |
| Component missing | 3 | 0.7% | 0.4% |
| Device handling problem | 3 | 0.7% | 0.7% |
FDA's device problem codes as entered on the report; one report can carry several. Generic codes such as "no apparent adverse event" are left out.
Patient problems coded
| Patient problem (FDA code) | Reports | Share |
|---|---|---|
| No patient involvement | 18 | 4.1% |
| Discomfortdiscomfort | 5 | 1.1% |
| Appropriate clinical signs, symptoms and conditions term/code not available | 4 | 0.9% |
| Painpain, site not specified | 3 | 0.7% |
| Urinary tract infectionbladder or urinary infection | 3 | 0.7% |
| Blistera blister | 2 | 0.5% |
| Blood loss | 2 | 0.5% |
| Erythemaskin redness | 2 | 0.5% |
| Hypersensitivity/allergic reaction | 2 | 0.5% |
| Skin irritationirritated skin | 2 | 0.5% |
| Skin tears | 2 | 0.5% |
| Urinary retentionbeing unable to empty the bladder | 2 | 0.5% |
| Hemorrhage/blood loss/bleeding | 1 | 0.2% |
| Inflammationinflammation | 1 | 0.2% |
| Injurya physical injury | 1 | 0.2% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Sl Foley Swivel Silicone Tricot 25bx | Product code EYJ | All MAUDE reports |
|---|---|---|---|
| Reports | 441 | 1,177 | 26,136,888 |
| Share of that pool | — | 37.5% | 0% |
| Classified as death, per 1,000 reports | 0 | 0 | 9 |
| Classified as injury | 2.3% | 5.1% | 36.2% |
| Classified as malfunction | 97.7% | 94.6% | 62.3% |
| Filed by the manufacturer | 100% | 98% | 94.9% |
Shares are of reports, not of devices in use. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."
Other brands with product code EYJ
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Sl Foley Swivel Silicone 25bx | 169 | 0 | 0% |
| Bard | 1,124 | 2 | 1.8% |
| Bardex I.C. Complete Care Foley Tray | 1,024 | 54 | 0% |
| Latex Foley Catheter | 1,368 | 7 | 0% |
| Unknown Latex Foley Catheter | 425 | 174 | 0% |
Ordered by report count for navigation only. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data." FDA also states that "common products may have a higher number of adverse events due to the higher total number of people using the product."
Questions about Sl Foley Swivel Silicone Tricot 25bx reports
How many FDA reports name Sl Foley Swivel Silicone Tricot 25bx?
441 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 0 in the latest 12 months.
What kinds of events are reported?
malfunction (97.7%) and injury (2.3%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
disconnection (47.8%), loss of or failure to bond (19.7%), difficult to open or close (7.9%), material fragmentation (7.5%) and fitting problem (6.6%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (100%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Sl Foley Swivel Silicone Tricot 25bx was at fault?
No. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data." FDA adds that "a causal relationship cannot be established between product and reactions listed in a report."
How do I report a problem with a medical device?
Through FDA MedWatch (Form FDA 3500 for health professionals and consumers), or to the manufacturer. See the guide on how to report.
Where this comes from. Counts are built from the openFDA Device Adverse Event (MAUDE) bulk export released 28 Sep 2026, which holds reports FDA received through 31 Aug 2026. Brand, generic and manufacturer names are as written on the reports; product code names come from FDA's device classification. A report counts here when any device it lists carries this brand name after punctuation and capitalisation are normalised. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.
Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.